FDA approves sNDA for Takeda’s Iclusig in Ph+ALL

The US Food and Drug Administration (FDA) has granted accelerated approved the supplemental new drug application (sNDA) for Iclusig (ponatinib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

Marketed by Japan’s largest drugmaker Takeda (TYO: 4502), Iclusig becomes the first and only targeted treatment approved in the USA for frontline Ph+ ALL in combination with chemotherapy. The news broke on what is a public holiday in Japan, so the was no stock market reaction.

Takeda noted that this approval is ground-breaking, marking the first FDA approval in Ph+ ALL based on the novel primary endpoint of minimal residual disease (MRD)-negative complete remission (CR). MRD-negative CR is a composite endpoint defined in alignment with the FDA that reflects deep molecular and clinical responses and is an important prognostic indicator for long-term outcomes for patients with Ph+ ALL.